Zalutumumab in Patients With Non-curable Head and Neck Cancer
NCT ID: NCT00382031
Last Updated: 2013-10-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
286 participants
INTERVENTIONAL
2006-11-30
2011-08-31
Brief Summary
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Detailed Description
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Patients randomized to treatment with zalutumumab in combination with BSC will receive weekly infusions with zalutumumab starting with a loading dose (8mg/kg) followed by weekly maintenance doses until disease progression, intercurrent illness preventing further administration, unacceptable toxicity or patient decision. After Visit 2 the patient should be evaluated for presence of skin rash prior to each infusion to allow dose titration.
Individual dose titration until the patient develops grade 2 skin rash will be applied. The maximum dose used in study will be 16 mg/kg.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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zalutumumab
Zalutumumab in combination with Best Supportive Care
Zalutumumab
Individual dose titration weekly i.v doses
Control
Best Supportive Care
Control
Best Supportive Care
Control
Best Supportive Care
Interventions
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Zalutumumab
Individual dose titration weekly i.v doses
Control
Best Supportive Care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy
3. Failure to at least one course of standard platinum-based chemotherapy
Exclusion Criteria
2. Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors
3. Past or current malignancy other than SCCHN, except for certain other cancer diseases
18 Years
ALL
No
Sponsors
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Genmab
INDUSTRY
Responsible Party
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Locations
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University Hospital Antwerp
Antwerp, , Belgium
St-Luc University Hospital
Brussels, , Belgium
CHNDRF
Charleroi, , Belgium
"University Hospital
Ghent, , Belgium
University Hospital Leuven
Leuven, , Belgium
Cliniques Saint Pierre
Ottignies, , Belgium
BioCancer
Belo Horizonte, , Brazil
Hospital Erasto Gaertner
Curitiba, , Brazil
Centro Goiano de Oncologia
Goiânia, , Brazil
Hospital Araújo Jorge
Goiânia, , Brazil
Fundação Amaral Carvalho
Jaú, , Brazil
CliniOnco
Porto Alegre, , Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, , Brazil
Cepho - Centro de Estudos e pesquisa em Hematologia e Oncologia
Santo André, , Brazil
Santo Andre Diag e Tratamentos
Santo André, , Brazil
Centro de Oncologia - InRad HCFMUSP
São Paulo, , Brazil
Hospital Heliópolis
São Paulo, , Brazil
IBCC - Instituto Brasileiro de Combate ao Câncer
São Paulo, , Brazil
UNIFESP
São Paulo - SP, , Brazil
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
London Regional Cancer Program
London, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
BC Cancer Agency
Vancouver, British Colombia, , Canada
North-Estonian Regional Hospital
Tallinn, , Estonia
Hôpital Beaujon- department of medical oncology
Clichy, , France
Centre Oscar Lambrette
Lille, , France
Centre Antoine Lacassagne
Nice, , France
Hôpital Tenon - department of medical oncology
Paris, , France
Institut Gustave Roussy
Villejuif, , France
Semmelweis University
Budapest, , Hungary
Uzsoki Hospital Budapest
Budapest, , Hungary
University of Debrecen
Debrecen, , Hungary
Petz Aladár
Győr, , Hungary
Szabolcs-Szatmar-Bereg County Hospital
Nyíregyháza, , Hungary
University of Szeged
Szeged, , Hungary
Markusovszky County Hospital
Szombathely, , Hungary
Szent Borbála County Hospital Oncology Department
Tatabánya, , Hungary
Zala County Hospital
Zalaegerszeg-Pózca, , Hungary
Klaipeda Hospital
Klaipėda, , Lithuania
Vilnius University
Vilnius, , Lithuania
Beskidzkie Centrum Onkologii
Bielsko-Biala, , Poland
Samodzielny Publiczny Szpital Kiniczny Nr1
Gdansk, , Poland
Katedra i Onkologii Collegium
Krakow, , Poland
Szpital Specjalistyczny im. Rydygiera
Krakow, , Poland
Centrum Onkologii
Lublin, , Poland
Zakład Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, , Poland
Centrum Onkologii - Instytut im. M. Curie-Skłodowskiej
Warsaw, , Poland
Dolnoslaskie Centrum Onkologii
Wroclaw, , Poland
Szpital Wojewódzki SP ZOZ
Zielona Góra, , Poland
Belgorod Regional Oncology Dispensary
Belgorod, , Russia
Regional Oncology Dispensary
Chelyabinsk, , Russia
Republican Clinical Oncology Dispensary
Izhevsk, , Russia
Kursk Regional Oncology Dispencary
Kursk, , Russia
Kursk Regional Oncology Dispensary
Kursk, , Russia
City Clinincal Oncology Dispensary #1
Moscow, , Russia
Moscow Research Institute of Oncology
Moscow, , Russia
NUZ Semashko Central Clinical Hospital No2 OAO
Moscow, , Russia
Russian Oncology Research Center n.a. Blokhin
Moscow, , Russia
GUZ NO Oncology Dispensary
Nizhiy Novgorod, , Russia
Medical Radiological Research Center
Obninsk, , Russia
St. Petersburg State Medical University
Saint Petersburg, , Russia
Sochi Oncology Center
Sochi, , Russia
Stavropol Regional Clinical Oncology Dispensary
Stavropol, , Russia
Tula Region Oncology Dispensary
Tula, , Russia
GUZ Volgograd Region Clinical Oncology Dispensary No1
Volgograd, , Russia
Voronezh Region Clinical Oncology Dispensary
Voronezh, , Russia
Institute for Oncology and Radiology
Belgrade, , Serbia
Military Medical Academy
Belgrade, , Serbia
Institute of Oncology Sremska Kamenica
Kamenica, , Serbia
Clinic of Maxillofacial Surgery Nis
Niš, , Serbia
Sahlgrenska University Hospital
Gothenburg, , Sweden
Lund University Hospital
Lund, , Sweden
Musgrove Park Hospital
Taunton, Somerset, United Kingdom
Royal Surrey County
Guildford, Surrey, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, , United Kingdom
The Beatson West of Scotland Centre
Glasgow, , United Kingdom
Royal Marsden Hospital
London, , United Kingdom
Christie Hospital
Manchester, , United Kingdom
Newcastle General Hospital
Newcastle, , United Kingdom
Weston Park Hospital
Sheffield, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Countries
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References
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Machiels JP, Subramanian S, Ruzsa A, Repassy G, Lifirenko I, Flygare A, Sorensen P, Nielsen T, Lisby S, Clement PM. Zalutumumab plus best supportive care versus best supportive care alone in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck after failure of platinum-based chemotherapy: an open-label, randomised phase 3 trial. Lancet Oncol. 2011 Apr;12(4):333-43. doi: 10.1016/S1470-2045(11)70034-1. Epub 2011 Mar 4.
Other Identifiers
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Hx-EGFr-202
Identifier Type: -
Identifier Source: org_study_id